Saturday, June 13, 2015

Propecia® MDL UPDATE: Dr. Imperato-McGinley Agrees To Deliver Requested Finasteride Clinical Trials Documents


UPDATED | 06.13.2015 @ 8 PM EDT: In response to Mr. I -- here is the letter/order mentioned below, as a PDF file. I obtained all of this from the US Courts' PACER electronic filing desk -- you need to sign up at the PACER virtual window, and pay ten cents a page for each download, via a valid credit card. As to putting the narrative together, it helps a lot to know what to look for -- and how to read the context, into what turns up. Note that the PDF contains the case file number at the top of each page, in blue. That's how you track a case's progress -- remotely. As to the substance, I actually suspect not much new will turn up, in the good doctor's files -- at least not anything the plaintiffs' lawyers haven't already sourced from Merck directly, in all likelihood. Now you know. Now. . . GO Hawks! End, Updated portion.

The June 19, 2015 previously-scheduled conference (and potential contempt of court hearing) in the US District courthouse, for the Eastern District of New York (Brooklyn) is now postponed -- to August, by agreed order.

The good doctor has agreed to turn over her documents. And the parties are speedily resolving their other production differences, we are told. There may still be some motion and briefing practice, as to a few of the issues remaining, but we will learn about that at the August 2015 conference. So, all as I predicted: no open fights, in Brooklyn in the near term.

. . . .An agreement has been reached with Dr. Imperato-McGinley, on the delivery of documents. . . .


So it goes. Onward. [Jurassic World was good fun, quite late last night.]

24 comments:

Anonymous said...

Mr. I here. Thanks much for the update. Do you have any links to where you're seeing this? And do you suspect that by August the two sides will have a better idea of where things stand in light of whatever does or does not turn up in Dr. I-M's documents?

Anonymous said...

By the way, glad to hear that you had a good night with Chris Pratt!

Condor said...

Thanks Mr. I -- your answers appear as an update, above. Take a look -- go Hawks!

Namaste

Anonymous said...

I'm certainly no lawyer but from a common sense point of view I am trying to figure out why this Doctor went to so much trouble to keep these documents out of the Plaintiff's hands if they already obtained all of this data from Merck? If that was the case wouldn't she have handed them over months ago and avoided all of this hoopla?








Anonymous said...

Mr. I here again. I'm also confused by that. Our blog host's explanation that most of this stuff would already be known makes sense to me, but your point also makes sense.

A possible explanation: perhaps one in Dr. Imperato-McGinley's position doesn't rush to do anything in a situation like this and needed to consult some experts about how to proceed? That is to say, perhaps the delay was just process and not necessarily anything too meaningful?

Condor said...

I suspect that the good doctor just feels like finding boxes full of perhaps 15 year old clinical trial documents (likely sent to storage)... Isn't one of her priorities.

We still might get surprised by a smoking gun document -- but it doesn't seem likely.

I think she's excited by her current research, and regards this MDL as a distraction -- and perhaps, a waste of her time. Some doctors are like that, in my experience.

Just my wild guesses, here. Namaste, all!

Anonymous said...

One thing I'm really curious about in this whole process is what happens if there is no proverbial smoking gun at all either in Dr. I-M's docs or whatever Merck and/or the FDA has. It doesn't seem impossible to me that post-finasteride syndrome or similar symptoms could indeed happen to some small but consistent % of users but that this didn't really show up in the research. What happens then? Is Merck off the hook? Could people still be compensated for some kind of negligence that's just not as incriminating as if Merck totally knew this drug was more dangerous? - Mr. I

Anonymous said...

My personal opinion is that there is a smoking gun somewhere. For example, it's pretty clear that Larry Bosley knew some things about Propecia in 1997 that made him very uncomfortable with it but just a few years later he started prescribing it to his patients anyways. That sure sounds like a "smoking gun" to me.

http://www.schmidtlaw.com/bosley-denounced-propecia-then-prescribed-it-to-patients/



Anonymous said...

Yeah, that does sound pretty bad. And it's actually crazy to think that a drug that works on some kind of mechanism that contributed to creating pseudohermaphrodites like what Dr. I-M discovered wouldn't have side effects. It seems like a classic example of messing with powers one couldn't possibly understand. - Mr. I

Condor said...

Please do continue the excellent discussion, here -- and while I offer no specific legal advice (ever, on this blog -- see disclaimer in lower left sidebar), nor am I creating any attorney-client relationship with these remarks. . . I'll quickly answer Mr. I (purely as a hypothetical matter), thus (drawing in a long breath now. . . smile):

After Wyeth v. Levine was decided by the United States Supreme Court (2012), as a matter of federal law, all Merck need do here is show that it had promptly added a sexual side effects warning on the label -- and that the FDA had approved that warning -- and that the warning spoke generally to the risks complained about (sexual side effects). That would be enough for Merck to be free from liability unless it knew of the risk, or could have known of it, with diligence at a much earlier time -- i.e., long before the label warning change. That's why the doctor's records are sought -- hoping to show a much earlier real risk -- of which, it will be argued, Merck could/should have been aware. But I think that unlikely.

Now, that doesn't mean all the plaintiffs are out of the box, entirely. They may sue the prescribing physician -- and most probably already have. There the claim will be that the doctor should have known, based on the label, and the generally not very robust hair growing results, this was an inappropriate risk for a given patient to take -- just to grow some peach fuzz on the top of his noggin'.

But the law on that score varies state-by-state -- so do talk to your own lawyer; do not rely on my largely unaided memory of the law, here.

Finally, to the last anon. commenter's point, it is important to distinguish the drug company -- from any prescribing physician. The latter may remain a defendant, even if the former escapes all liability.

SO -- for what it is worth, do talk to your own personal lawyer about your state's version of the law about prescribing physicians' liability, here. That is a state by state question.

Anonymous said...

Thank you for that, and I do understand that there's no official legal advice being given here. For what it's worth, I found the blog of Max Kennerly to be really helpful in understanding the state of drug litigation. He makes it sound like the drug companies these days are usually pretty protected but for cases where they failed to properly warn, and that seems like it could be the case here (especially if a proverbial smoking gun should appear). Personally, it never occurred to me to sue the prescribing physician. Are they not also somewhat at the mercy of what information is made available? I suppose a physician today might need to be more careful about Propecia / Finasteride given the updates to the labeling, but what about someone who prescribed it in the years after it was approved when the only real warning was the 2% and it goes away as long as you quit the drug (i.e., no real risk) labeling? - Mr. I

Condor said...

I hear you Mr. I --

In the end, it is the doctor's advice, in theory, at least -- that patients should rely upon. There is no personal relationship with the drug companies.

Doctors are supposed to decide what's an acceptable risk vs. benefit, for a patient -- on a drug.

But I represent lots of doctors, too -- and they usually are working with less than perfect information -- making educated guesses, so. . .these are tough cases.

That is, I think we all will have to wait and see how it plays out, in the doctor's documents.

Namaste

Anonymous said...

This is definitely good discussion. I still feel that the Propecia labeling change in 2012 could play a big part in how this turns out. The original label did warn of side effects but stated they would eventually go away after discontinuation. We now know years later that information was not accurate and the labeling change officially confirmed as much. I understand that it needs to be proven that Merck knew of the risk before or during the clinical trials and I'm sure that's why these documents were so highly sought after. As you say, lets see how it all plays out.

Anonymous said...

Yeah, the label change seems to be somewhat incriminating in and of itself especially considering that there are different label changes in different countries now? Another thing I'm a bit confused about is how I'd seen mentioned that "belwether" cases in October of 2016 as if that was already a done deal, but it would seem that there's always a chance of new information coming to light that changes everything? This is all new territory for me, so I'm just trying to see how all of the pieces fit together. - Mr. I

Anonymous said...

Correct, belwether trials have been scheduled for October 2016. They may or may not happen depending on what comes to light over the next year or so. Either settlement talks will eventually start to heat up or Merck will opt to wait and see how the initial belwether trials turn out before going down that road.

Blog owner, feel free to correct me on anything I said here. Since I post here quite a bit I guess I need a name as well... I'll go with "Mr. E"





Anonymous said...

OK, thanks. There's one other particularly interesting bit to all of this, or at least I find it particularly interesting. I have to think that the main issue that the plaintiffs are bringing here (sexual dysfunction) is one that is unusually embarrassing. To go into a court room and talk about your brain fog is one thing, but to go into a court room and talk about impotence is another. I wonder to what extent if at all this plays into the thinking of Merck. Might they be a bit more confident than usual for a litigation like this because they would think people might be more willing to settle than usual (i.e., less willing to take this into a court room)? I could be wrong. It might be nothing. And maybe there are a few folks out there so outraged by what they think happened that they're actually more inclined to get in there, but my hunch would be that most plaintiffs would not relish the thought of being in a court room talking about his. - Mr. I

Anonymous said...

Take it for what it's worth, but my gut feeling is that there will be some sort of settlement before these cases make it to trial. No inside knowledge here, just my hunch. However, if I'm wrong and it goes to trial I doubt that many (if any) of the plaintiffs would come this far only to "jump ship" right near the finish line after coming this far.

Mr. E

Anonymous said...

I have one more question for Condor or anyone else. When this hearing does happen in August, what is the public likely to learn if anything? - Mr. I

Condor said...

Assuming the discovery disputes are ironed out, by August, not much. . .

I think the other commenters are right that Merck is likely to let a bellwether case or two go to trial, and jury verdict, before even seriously considering settlement discussions -- to that puts the MDL in a July 2016 posture, at the earliest for any real resolution, or settlement information.

I actually think the August date will simply be a status hearing, very perfunctory.

As I say, this is a long and winding road, yet to travel.

I wish it weren't so -- but I suspect it is.

Namsate, one and all. . .

Anonymous said...

Heh - Assuming you're referring to Mr. E, I think he was saying that he thought Merck would NOT let it get to the belwether. I have to think though that you, Condor, are likelier correct. Does not an entity like Merck have a slew of money stockpiled away for a situation this as a cost of doing business? Again, this is all new to me, so this is all kind of "gut" for me, but I'm just not expecting this to go easily for the plaintiffs unless something pretty crazy comes out in discovery. - Mr. I

Condor said...

Sorry -- mine above should have referred to December 2016, not July.

And while Merck does have reserves on the books for this MDL, those reserves are calculated only to cover estimated legal fees -- not payouts to claimants.

So yes -- I expect this will take quite a while yet.

If and when Merck settles, it will take a special charge to EPS, in order to cover the likely payout totals....

But that would be a 2017 event.

Namaste.

Anonymous said...

Yeah, I'm just going off my own gut feeling as well. Without knowing what has come out in discovery none of us really know at this point. If there is going to be a settlement prior to the belwether trials I would guess that we would start to hear rumblings about it in early 2016.

Mr. E

Condor said...

Thanks Mr. E -- and all:

Just a minor update here -- the Eastern District of New York has selected the date for the next in-court status conference. It will be held August 26, 2015 at 2:00 p.m., as ordered by Magistrate Judge Viktor V. Pohorelsky. . . .

So -- we do know the good doctor will have delivered her documents well before that date.

We may not know exactly what all she delivered, though -- and whether her files were worthy of all this. . . hoopla.

Namaste

Anonymous said...

Thanks for all the great updates here folks and keeping everyone in the loop on this Propecia matter.
It is my opinion that the only matter that is going to be dealt with and settled in the August 26,2015 conference is to see how many claims that Merck is able to throw out of litigation. They have a litigation firm (that they do lots of business these days with) and it is there job to dismiss as many cases as possible based on any technical reason they can come up with.
As far as clinical trial papers goes what is to say that this doctor and Merck have not had all the time in the world to go through them and destroy all record of anything that puts them in a bad light ? How many years have they had to do the manipulation on what is turned over to the court ?